Clinical trial
A Randomized Blinded Placebo Controlled Trial Assessing Ketorolac (Toradol) at Oocyte Retrieval
Name
TORA-IVF-01
Description
To determine if a nonsteroidal anti-inflammatory drug (NSAID), Ketorolac (Toradol), can improve pain control and decrease narcotic use after undergoing egg retrieval.
Trial arms
Trial start
2022-08-10
Estimated PCD
2023-12-01
Trial end
2025-01-01
Status
Recruiting
Phase
Early phase I
Treatment
Ketorolac (Toradol)
IV Ketorolac (Toradol) will be administered at conclusion of oocyte retrieval. All enrolled patients will receive standard post-operative pain management.
Arms:
Standard post-operative pain management + Ketorolac (Toradol)
Placebo (saline)
IV Placebo (saline) will be administered at conclusion of oocyte retrieval. All enrolled patients will receive standard post-operative pain management.
Arms:
Standard post-operative pain management + Placebo (saline)
Size
400
Primary endpoint
Administration of IV narcotic for rescue analgesia during recovery in the post anesthesia care unit (PACU)
Oocyte retrieval procedure day
Eligibility criteria
Inclusion Criteria:
1. Signed informed consent
2. Females over 18 years of age who are scheduled to undergo oocyte retrieval
3. Patients must be able to read and understand written English or have an appropriate certified medical translator available.
4. Standard eligibility criteria to undergo IVF and embryo transfer at Shady Grove
Exclusion Criteria:
1. Known allergy to ketorolac
2. Those with known medical conditions precluding them from ketorolac use (active peptic ulcer disease, recent or history of hemorrhage or perforation, known renal or hepatic insufficiency, suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, bleeding disorders, recent myocardial infarction, or stroke.)
3. BMI ≥ 40 kg/m2
4. History of substance abuse
5. Chronic opioid use
6. Transabdominal oocyte retrieval
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Allocation group will not be disclosed to the patient or the physician or the nurse or the outcome assessor. The anesthesia provider administering the IV Ketorolac or Placebo will be unblinded.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}
Updated at
2023-09-07
1 organization
1 product
5 indications
Product
KetorolacIndication
infertilityIndication
WomanIndication
Oocyte RetrievalIndication
Postoperative PainIndication
In Vitro Fertilization